MI VARNISH
Received May 22, 2013 · Event occurred Apr 24, 2013
Report 1410097-2013-00002 · MDR key 3129721
Device
Product problems
- Use of Device Problem
Patient
14 YR
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
NO SAMPLES RECEIVED FROM DENTIST. EVALUATION BASED ON PHONE INTERVIEW. WE WILL CONTINUE TO MONITOR POSSIBLE ISSUES RELATED TO CAUTION STATEMENT.
Description of Event or Problem
ALLERGIC REACTION TO PRODUCT. DENTIST OFFICE SAID THEY PLACED VARNISH IN PATIENT ON (B)(6) 2013, NOT THINKING ABOUT THE RECALDENT IN THE PRODUCT. UPON PLACEMENT, PATIENT'S FACE AND LIPS STARTED TO SWELL UP. PATIENT'S MOTHER WAS THERE IN THE OFFICE AND GAVE HER SON A BENADRYL TABLET AND DENTIST'S STAFF QUICKLY REMOVED ALL VARNISH AND HAD PATIENT RINSE OUT. PATIENT'S SYMPTOMS SUBSIDED IN OFFICE AS PATIENT SAT IN OFFICE AND WAITED FOR BENADRYL TO WORK. ALSO, ALTHOUGH MOTHER HAD EPI PEN, IT WAS NOT NEEDED.
Remedial action
- Other